Indications

– Treatment of status asthmaticus, laryngitis stridulosa, severe allergic conditions, serum sickness.
– It is used in combination with other therapies in treatment of cerebral edema, shock due to various causes.
– It is given antenatally to mothers at risk of premature delivery in order to hasten fetal lung maturation and help prevent neonatal
respiratory distress syndrome.
– Adjunctive therapy in bacterial meningitis.

Present

Bottle of 200 tablets. Box of 1 bottle.

Composition

Dexamethasone acetate…………………………0.5mg
Excipients s.q. for ………………………………1 tablet
(Corn starch, Lactose, Tartrazine, Magnesium stearate, Colloidal silicon dioxide, Cassava starch).

Pharmacology

– Dexamethasone is fluoromethylprednisolone, a synthetic glucocorticoid. Glucocorticoid works by binding to glucocorticoid receptors in the cytosol and is translocated into the nucleus and is bound to glucocorticoid response element that exerts its action upon gene expressions that controls the development, metabolism, and immune response. Some glucocorticoids may exert direct actions, without being bound to glucocorticoid response element.
– Dexamethasone possesses potent anti– inflammatory, anti– allergic and immune suppression action. In anti– inflammatory activity, Dexamethasone is 30 times more potent than Hydrocortisone and 7 times more potent than Prednisolone.

Pharmacokinetics

– Dexamethasone appears to be readily absorbed when administered orally, rapidly distributed to body tissues.
– Dexamethasone crosses placenta and is secreted into breast milk.
Its half– life is about 190 minutes. In the body Dexamethasone is bound to plasma proteins (about 77%). Dexamethasone is metabolized slowly
and primarily in the liver and excreted mainly via urine.

Contra-Indications

– Hypersensitivity to any ingredient of the medicine.
– Systemic fungal infections, viral infections, uncontrolled tuberculous or gonorrheal infections, severely deformed joints.

Side effect

– Electrolytes balance disturbance: hypokalemia, sodium and fluid retention result in increase blood pressure and edema.
– Endocrine and metabolism disturbance: Cushing’s syndrome, decrease in ACTH secretion, adrenal cortex atrophies, decrease glucose tolerance, menstrual disorders.
– Musculoskeletal effects: reversible muscle atrophy, osteoporosis, pathological fractures of long bones, vertebral compression fractures,
aseptic necrosis of femoral or humeral heads.
– GI system effects: gastro– duodenal ulcer, hemorrhaging ulcers, perforating ulcers, acute pancreatitis.
– Skin effects: skin atrophy, erythema, black eye, hirsutism.
– Nervous effects: insomnia, euphoria.
Inform your doctor about side– effects when using this medicine.

Precaution

– Pay special care in patients with infections or suspected infection and prior to its initiation the infection should be addressed first with effective antibacterial agent, because of its immunosuppressive effect.
Dexamethasone may lead to exacerbation of serious infections or dissemination of localised infections. But in patients with bacterial meningitis, Dexamethasone should be given before giving specific antibacterial agents in order to avoid encephalitis due to reaction to anti– infective liberated bacterial endotoxin and cell wall components.
– In patients with osteoporosis, or have recently undergone intestinal surgery, psychosis, peptic ulcer, diabetes mellitus, blood hypertension,
cardiac insufficiency, renal impairment, tuberculosis care should be taken to monitor and treat those conditions before taking to Dexamethasone
therapy.
– Caution should be exercised when giving this drug to patients who are driving vehicle or operating machinery.
PREGNANCY & LACTATION:
– Caution should be exercised when it is given to pregnant women.
– Do not breastfed while on corticosteroid therapy.

Interaction

– Barbiturates, Phenytoin, Rifampicin, Rifabutin, Carbamazepine, Ephedrine, Aminoglutethimide may increase corticosteroids clearance therefore decrease its therapeutic effects.
– Corticosteroids antagonise the effects of hypoglycemic, hypotensive and diuretic agents. Potassium depleting diuretics such as Thiazide,
Furosemide and Amphotericin B may increase blood potassium depletion of corticosteroid.
– Salicylate clearance may be increased when it is used concomitant with Salicylate, therefore when it is stopped abruptly may lead to Salicylate poisoning.
– Concurrent use of Dexamethasone may result in diminished effect of Mifepristone, Vaccines.
OVERDOSAGE & MANAGEMENT:
– There is not a specific antidote for Dexamethasone overdosage. The management of acute overdose consists of general supportive measures
and symptomatic relief.
– If anaphylaxis or hypersensitivity occur, those allergic reactions can be managed by Epinephrine, artificial ventilation and Aminophylline.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 30^oC. Protect from light.

Dosage

– As prescribed by the physician.
– The dosage may be adjusted according to the kind of the disease, response to the therapy and patient’s status. The drug should be administered in the smallest dosage possible that is effective in order to minimize the risk of adverse effects.
– Recommended dosage: Adults: 1 – 6 tablets daily.
Children: ½ – 4 tablets daily.
– Taken after meals. Do not stop administration abruptly but reduce the dosage gradually.